Authorized purpose: Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Which images or clinical context are in scope?Modality: Mammography/DBT Anatomy or clinical context: Breast Input: Standard DICOM FFDM mammograms from compatible systems; validation used standard four-view 2D images from Hologic, GE Healthcare and Siemens.
Who uses it?Intended users: Physicians interpreting screening mammograms
What does the software produce?Output: Color, single-color, grayscale or combined heatmaps of suspicious areas and an abnormality score for each breast. Version 1.1.10 updates the AI model and removes the one-view Secondary Capture output mode.
What is its most important limitation?Key limitation: Physician review of the complete examination and patient history remains necessary. Results are viewed after the initial read; this authorization does not replace clinical judgment or establish autonomous screening or DBT analysis.
Clinical takeaway
Clinical role: Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Evidence takeaway
Evidence from the reviewed source record: The exact v1.1.10 standalone study is available with threshold and population context. Four stored family trial leads do not establish linkage to this release. The summary's AUC acceptance statement needs clarification.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM systems, viewed after the physician's initial read as an adjunct to complete clinical interpretation.
Color, single-color, grayscale or combined heatmaps of suspicious areas and an abnormality score for each breast. Version 1.1.10 updates the AI model and removes the one-view Secondary Capture output mode.
Physician review of the complete examination and patient history remains necessary. Results are viewed after the initial read; this authorization does not replace clinical judgment or establish autonomous screening or DBT analysis.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Current hosting model, region, hardware, latency and retention for v1.1.10 were not established by the reviewed sources.
Security and privacy
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
No current dated, scoped security attestation or installed data-flow/access-control package was established.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Vendor family program support mentions training, but the v1.1.10 curriculum, responsibilities and support term are not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Editorial acceptance question: verify the installed model, default operating point, supported FFDM systems and post-initial-read display sequence; supplied monitoring commitments remain unknown.
Vendor family commercial program
The current Lunit product page describes SecondRead AI as an optional out-of-pocket breast-screening analysis program with radiologist review, training and program materials.
product family ยท checked 2026-09-05
No exact v1.1.10 linkage, price or payer determination; regional availability requires confirmation.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
The exact v1.1.10 standalone study is available with threshold and population context. Four stored family trial leads do not establish linkage to this release. The summary's AUC acceptance statement needs clarification.
DesignManufacturer standalone evaluation on a held-out multi-facility US FFDM dataset
PopulationAdult female screening mammography cases, Hologic/GE/Siemens acquisitions; enriched validation composition is not a routine screening prevalence estimate
Scopeexact submission
Tested versionLunit INSIGHT MMG v1.1.10
Samplen=2412
Sites28
IndependenceSponsor or vendor study
K260320
Two or three breast radiologists defined truth using clinical and pathology evidence. Printed AUC lower bound 0.896 conflicts with the claimed greater-than-0.903 criterion; no independent reader benefit for this release is inferred.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
The current vendor page mentions optional out-of-pocket SecondRead AI, but gives no verified v1.1.10 price, contract unit or included services.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-05
No applicable CMS national/local policy content was reviewed. A vendor's optional out-of-pocket program does not establish payer coverage or noncoverage.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify deployment and data flow: Current hosting model, region, hardware, latency and retention for v1.1.10 were not established by the reviewed sources.
Verify security and privacy controls: No current dated, scoped security attestation or installed data-flow/access-control package was established.
Verify training: Vendor family program support mentions training, but the v1.1.10 curriculum, responsibilities and support term are not established.
Verify pricing and total cost: The current vendor page mentions optional out-of-pocket SecondRead AI, but gives no verified v1.1.10 price, contract unit or included services.
Verify reimbursement and coding relevance: No applicable CMS national/local policy content was reviewed. A vendor's optional out-of-pocket program does not establish payer coverage or noncoverage.
Verify local validation and lifecycle monitoring: Editorial acceptance question: verify the installed model, default operating point, supported FFDM systems and post-initial-read display sequence; supplied monitoring commitments remain unknown.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
4Screened trial leads
0Unreviewed FDA recall leads
All four stored trial titles and sponsors were screened. They are plausible Lunit family leads but metadata does not identify v1.1.10/K260320; no trial result is promoted. Full registry content and release linkage remain pending. No stored PubMed candidates. The current discovery snapshot contains 0 PubMed and 4 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, acr ai central product, literature index, trial registry, fda decision summary, vendor product page, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history7 sources - 3 history items
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